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RECRUITING
NCT07121712
NA

Navigated cTBS for the Treatment of Generalized Anxiety Disorder

Sponsor: WANG KAI

View on ClinicalTrials.gov

Summary

The purpose of this study is to investigate the effectiveness of a non-invasive brain stimulation technique called continuous Theta Burst Stimulation (cTBS) for treating Generalized Anxiety Disorder (GAD). The researchers will use a neuronavigation system, which acts like a GPS for the brain based on a participant's own MRI scan, to guide the stimulation to a specific target in the brain's auditory association cortex. This area is involved in processing information and may play a role in anxiety. Participants who enroll will be randomly assigned to one of two groups. One group will receive active cTBS treatment, while the other will receive a sham (placebo) stimulation that feels similar but has no therapeutic effect. The treatment will be given three times a day for seven consecutive days. Before and after the treatment period, all participants will complete clinical questionnaires to measure their anxiety and related symptoms. They will also undergo Magnetic Resonance Imaging (MRI) scans to help researchers understand how cTBS affects brain activity. A follow-up assessment will be conducted two weeks after the treatment ends to check on symptoms.

Official title: Efficacy and Neural Mechanisms of Navigated Continuous Theta Burst Stimulation (cTBS) for Generalized Anxiety Disorder (GAD)

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-09-09

Completion Date

2026-08-31

Last Updated

2025-09-10

Healthy Volunteers

No

Interventions

DEVICE

Mapsd Continuous Theta Burst Stimulation

A non-invasive brain stimulation technique using a MagStim Rapid2 stimulator with a 70mm air-cooled figure-of-eight coil. The stimulation target is the left auditory association cortex (MNI: -62, -40, 10), located using a Brainsight neuronavigation system. The cTBS protocol consists of 3-pulse 50 Hz bursts repeated at a 5 Hz frequency for a total of 600 pulses, delivered at 100% of the individual's resting motor threshold (RMT).

DEVICE

Sham Navigated Continuous Theta Burst Stimulation

A placebo procedure using an inert sham coil that is identical in appearance and sound to the active coil but does not deliver a significant magnetic field to the cortex. All other aspects of the procedure, including neuronavigation, coil placement, duration, and sound, are identical to the active intervention to maintain the blind.

Locations (2)

Anhui Medical University

Hefei, Anhui, China

Anhui Medical University

Hefei, Anhui, China